capitol hill report: COVID-19 VACCINATIONS, ADUCANUMAB, AND MORE

January 24, 2022

COVID-19 Vaccinations, Aducanumab, and More

Latest Advocacy News

• On January 13, the Supreme Court upheld the vaccine requirement for health care workers in facilities accepting Medicare or Medicaid payments, while blocking the Occupational Safety and Health Administration’s vaccine or test requirements for large private companies. The AAN has advocated for such a mandate since early last year and submitted official comments in support of this rule in December.
• Neurology on the Hill is heading back to Washington, DC! Join us May 23–24 at the Ritz-Carlton, Pentagon City, where selected participants will learn how to develop relationships with members of Congress and promote AAN issues and solutions to problems that neurologists face. Apply today.
• On January 6, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule aimed at lowering out of pocket costs for Part D drugs, improving health equity, and improving consumer protections. Key provisions include a requirement to pass through discounts at the pharmacy counter, efforts to promote Medicare Advantage network adequacy, and protections for dual-eligible beneficiaries. The AAN is currently reviewing the proposed rule and plans to submit comments.

Issue in Focus

CMS Proposes Limited Coverage of Aducanumab
On January 11, CMS released its proposed National Coverage Determination (NCD) relating to monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (AD). This NCD is the culmination of a National Coverage Analysis that was triggered by the FDA’s approval of aducanumab (brand name Aduhelm) in June 2021.

This proposed NCD would limit the coverage of aducanumab, and all other beta amyloid targeting monoclonal antibodies for the treatment of AD, to patients who are participating in a CMS-approved clinical trial. This would happen through a process known as Coverage with Evidence Development (CED) which is a mechanism used by CMS to continue to gather data on certain therapies with lingering questions around safety or effectiveness. Eligibility for these trials will be limited to patients with proven beta amyloid positivity who are suffering from mild cognitive impairment or mild AD, which is in alignment with the population studied in the original clinical trials for aducanumab.

The AAN has been engaging with the FDA, CMS, and other key stakeholders on issues relating to aducanumab. This NCD realizes many of the AAN’s advocacy efforts such as coverage of PET to confirm amyloid positivity for prospective patients, limitation of coverage to patients with mild cognitive impairment or mild AD, further clinical trials to confirm clinical benefit, and more inclusive trial data to reflect the diverse patient population affected by AD. The AAN will submit official comments in response to the NCD, and members may also comment within the 30-day comment period. CMS will announce a final decision by April 11. Find more information and resources on our Aducanumab Resources page.

What We're Reading

• Could viruses cause Alzheimer's? COVID-19 brain studies offer new clues (National Geographic)
• Democrats fret about delivering on health care promises ahead of midterms (The Washington Post)
• CMS extends COVID-19 vaccine deadline for health workers in 24 states (Healthcare Dive)